A Study to Evaluate the Efficacy and Safety of Safinamide, as add-on Therapy, in Idiopathic Chinese Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Stable Doses of Levodopa
Parkinson Disease
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria:
- Male or female patients aged ≥18 years old.
- Chinese ethnicity.
- Able to understand and willing to provide written informed consent.
- Able to maintain an accurate and complete 24-hour diary with the help of a caregiver.
- Diagnosis of idiopathic Parkinson's Disease (IPD) using the United Kingdom Parkinson's Disease Society Brain Bank criteria of more than 3 years duration.
- Be levodopa responsive and receiving treatment with stable daily doses of oral L-dopa, with or without benserazide/carbidopa, with or without addition of a catechol-O-methyltransferase (COMT) inhibitor and may be receiving concomitant treatment with stable doses of dopamine agonists, anticholinergics and/or amantadine for at least 4 weeks prior to the screening visit.
- A Hoehn and Yahr stage between 1-4 inclusive during the "ON" phase.
- Experiencing motor fluctuations with a minimum of 1.5 hours/day of "OFF" time during the day (excluding morning akinesia), based on historical data.
If female, be post-menopausal for at least one year or have undergone hysterectomy or, if of child-bearing potential, must have a negative pregnancy test, must not be breast-feeding nor become pregnant during the study and must use adequate contraception for 1 month prior to randomisation and for up to 1 month after the last dose of study drug. Adequate contraception is defined as:
- Hormonal oral, implantable, transdermal, or injectable contraceptives or a non-hormonal intrauterine device or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit;
- a male sexual partner who agrees to use a male condom with spermicide or a sterile sexual partner . For all women of child-bearing potential, urine pregnancy test result at screening must be negative.
For all women of child-bearing potential, urine pregnancy test result at screening must be negative.
Exclusion Criteria:
- Any form of Parkinsonism other than IPD.
- Diagnosis of chronic migraine (>15 days per month) or cancer pain.
- L-dopa infusion.
- Hoehn and Yahr stage 5 during the "ON" phase.
- If female, pregnancy or breast-feeding.
- Neurosurgical intervention of PD or stereotactic brain surgery.
- Severe peak dose or biphasic dyskinesia, unpredictable or widely swinging fluctuations.
- History of major depression or other clinically significant psychotic disorder which compromise the ability to provide the informed consent or to participate to the study.
- Drug and/or alcohol abuse within 12 months prior to the screening visit.
- History of dementia or severe cognitive dysfunction.
- Use of any investigational drug or device within 30 days prior to screening or 5 half-lives, whichever is the longest, or during the study.
- Allergy/sensitivity or contraindications to the investigational medicinal products (IMPs) or their excipients, to anticonvulsants or to anti-Parkinson drugs.
- Any clinically significant condition (including laboratory values) which, in the opinion of the Investigator, would not be compatible with study participation or represent a risk for patients while in the study.
- Moderate or severe liver failure using the Child-Pugh classification score, or human immunodeficiency virus (HIV) infection.
- Treatment with monoamine oxidase inhibitors (MAOIs), pethidine, opiates, opioids, fluoxetine, fluvoxamine in the 4 weeks prior to the screening visit. These drugs are not allowed throughout the study and up 2 weeks after the last dose of study drug.
- Ophthalmologic history including any of the following conditions: albinism, uveitis, retinitis pigmentosa, retinal degeneration, active retinopathy, severe progressive diabetic retinopathy, inherited retinopathy or family history of hereditary retinal disease.
Sites / Locations
- Sir Run Run Shaw Hospital, Zhejiang University 浙江大学医学院附属邵逸夫医院
- Shanghai Ninth People's Hospital 上海交通大学医学院附属第九人民医院
- Tianjin Union Medicine Center 天津市人民医院
- The Third Xiangya Hospital of Central South University 中南大学湘雅三医院
- Renmin Hospital of Wuhan University 武汉大学人民医院
- Sichuan Provincial People's Hospital 四川省医学科学院·四川省人民医院
- West China Hospital, Sichuan University 四川大学华西医院
- Beijing Friendship Hospital 首都医科大学附属北京友谊医院
- Beijing Tiantan Hospital Affiliated to Capital Medical University 首都医科大学附属北京天坛医院
- The First Bethune Hospital of Jilin University
- The First Hospital of Shanxi Medical University 山西医科大学第一医院
- The Second Affiliated Hospital of Zhejiang University 浙江大学医学院附属第二医院
- The Second Affiliated Hospital of Nanchang University 南昌大学第二附属医院
- Guangzhou First People's Hospital 广州市第一人民医院
- Shanghai General Hospital 上海市第一人民医院
- Sun Yat-sen Memorial Hospital 中山大学孙逸仙纪念医院
- Tongji Hospital of Tongji University 同济大学附属同济医院
- The Third Hospital of Hebei Medical University 河北医科大学第三医院
- Chongqing Three Gorges Central Hospital 重庆三峡中心医院
- Shanghai Ruijin Hospital 上海交通大学医学院附属瑞金医院
- The First Affiliated Hospital of Baotou Medical University 内蒙古科技大学包头医学院第一附属医院
- Baotou City Central Hospital 包头市中心医院
- The Affiliated Hospital of Xuzhou Medical University 徐州医科大学附属医院
- The Affiliated Hospital Of Guiyang Medical College 贵州医科大学附属医院
- The First Affiliated Hospital of Guangzhou Medical University 广州医科大学附属第一医院
- Wenzhou Medical College-The First Affiliated Hospital 温州医科大学附属第一医院
- Daqing Oilfield General Hospital 大庆油田总医院
- Fujian Medical University Union Hospital 福建医科大学附属协和医院
- Qilu Hospital of Shandong University 山东大学齐鲁医院
- Nanjing Drum Tower Hospital 南京鼓楼医院
- The second affiliated hospital of Soochow University 苏州大学附属第二医院
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Safinamide
Placebo
Patient will receive film-coated Safinamide tablets orally at an initial dose of 50 mg once daily (OD) and then will be increased the day after the Visit 3/week 2 (ideally at day 15) to the final dose of 100 mg OD. Treatment will continue daily for a total of 16 weeks.
Patient will receive matching placebo orally at an initial dose of 50 mg once daily (OD) and then will be increased the day after the Visit 3/week 2 (ideally at day 15) to the final dose of 100 mg OD. Treatment will continue daily for a total of 16 weeks.